A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

Part of paid clinical trials in Lake Forest, California.

Sponsor
Amgen
Study ID
NCT07590193
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AMG 127 — DRUG
    AMG127 will be administered as either a SC injection or as an IV infusion.
  • Placebo — DRUG
    Placebo will be administered as either a SC injection or as an IV infusion.

Study Details

The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).

Key Dates

First listed
May 15, 2026
Start date
Jun 11, 2026
Status verified
Jul 2026
Primary completion
Oct 2, 2027
Completion
Oct 2, 2027

Study Design

Enrollment
162 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single Ascending Dose (SAD)
    Participants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection. One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.
  • Experimental: Part B: Multiple Ascending Dose (MAD)
    Participants will receive multiple ascending doses of AMG 127 via SC injection.
  • Experimental: Part C: Proof of Mechanism (PoM)
    Participants will receive multiple doses of AMG 127 via SC injection.
  • Placebo Comparator: Placebo
    Participants will receive a matching placebo as either a SC injection or as an IV infusion.

Primary Outcome Measure

Number of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orange County Research CenterLake ForestCalifornia92630-
Translational Clinical Research LLCAventuraFlorida33180-

Find similar trials in Lake Forest, CA

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By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Orange County Research Center· Lake Forest, CATranslational Clinical Research LLC· Aventura, FL

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